# K113733: Small and Large Fragments Osteosynthesis System Neofix

- Pathway: 510(k) (Traditional)
- Applicant: Neoortho Produtos Ortopedicos S/A
- Decided: Mar 23, 2012 after 95 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K981372 (1998). 40 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 2.
- K071715: Acumed Congruent Bone Plate System, Acumed, LLC (2007) Summary page 2.
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 2.
- K101421: Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates Model 131218704-708; 851318704-708, 131218204, DePuy Orthopaedics, Inc. (2010) Summary page 2.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 2.
- K000558: Synthes (Usa) Wrist Fusion Plates (WFP), Synthes (Usa) (2000) Summary page 2.
- K020401: Synthes Calcaneal Plate, Synthes (Usa) (2002) Summary page 2.
- K020602: Synthes Pilon Plate, Synthes (2002) Summary page 2.
- K023802: Synthes 4.5 MM Titanium LCP Proximal Tibia Plating System, Synthes (Usa) (2003) Summary page 2.
- K092609: Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP), Synthes (Usa) (2009) Summary page 2.
- K081353: Synthes (Usa) Tomofix Medial Distal Femur Plates, Synthes (Usa) (2008) Summary page 2.
- K023941: Synthes Tomofix Osteotomy System, Synthes (Usa) (2003) Summary page 3.
- K000089: Synthes 4.0 and 5.0 MM Locking Screws, Synthes (Usa) (2000) Summary page 3.
- K041533: Synthes (Usa) [Synthes} Peri-Prosthetic Screws, Synthes (Usa) (2004) Summary page 3.
- K033995: 3.5 MM LCP Distal Humerus System, Synthes (Usa) (2004) Summary page 3.
- K043185: Synthes 3.5MM Cortex Screws, Synthes (Usa) (2005) Summary page 3.
- K961413: Synthes Anatomical Locking Plate System, Synthes (Usa) (1996) Summary page 3.
- K061621: Synthes (Usa) 6.5 MM Cancellous Screws, Synthes (Usa) (2006) Summary page 3.
- K031573: Synthes 3.5 MM Low Profile Pelvic Reconstruction Plate, Synthes (Usa) (2003) Summary page 3.

## Cited in the summary but kept off the family tree
- K071815: Noveon, Model LS1100-01-0968, Nomir Medical Technologies, Inc. (2007). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K061376: EL-Anca: Anti-Mpo, Anti-PR3, Anti-Mpo and Anti-PR3, Theratest Laboratories, Inc. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K142419: Mini and Micro Fragments Reconstruction System-NEOFIX (2014), 8 descendants of its own
- K182718: Mini and Micro Fragments Reconstruction System – GMReis (2019), 4 descendants of its own
- K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own
- K242596: Versalock Mini and Micro Plating System (2024), 2 descendants of its own
- K260390: Super Upper Limbs Versalock Plating System (2026), 1 descendant of its own

## Indications for use
Small and Large Fragments Osteosynthesis System NEOFIX is intended for small and large bone fracture fixation, arthrodesis and osteotomy fixation. Examples include: fractures of the clavicle, scapula, humerus, olecranon, radius, ulna, carpals, metacarpals, distal femur, proximal tibia, tibial pilon, fibula, calcaneus, tarsals and metatarsals; small fragments of the hand and wrist; pelvis and acetabulum fractures; periprosthetic fractures; metatarsal and phalangeal osteotomies; and carpal, metacarpal, wrist and ankle arthrodesis. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone. This system is not indicated for use in the spine.

Source page: https://510kreport.com/device/K113733
Methodology: https://510kreport.com/methodology